Procelac capsules

Procelac

  • Active Ingredient: Omeprazole
  • 40 mg, 20 mg, 10 mg
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What is Procelac?

The active ingredient of Procelac brand is omeprazole. Omeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach. Omeprazole, USP is a white to off-white crystalline powder that melts with decomposition at about 155В°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of Omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of Omeprazole in the form of enteric-coated beads with the following inactive ingredients: ammonium hydroxide, dibutyl sebacate, D&C Yellow No. 10, FD&C Green No. 3, gelatin, ethylcellulose, fumed silica, hypromellose, methacrylic acid, oleic acid, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 40 mg empty gelatin capsule shell also contains FD&C Blue No. 1. In addition, the white imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide. Meets USP Dissolution Test 2.

Used for

Procelac is used to treat diseases such as: Barrett's Esophagus, Duodenal Ulcer, Erosive Esophagitis, Gastritis/Duodenitis, GERD, Helicobacter Pylori Infection, Indigestion, Multiple Endocrine Adenomas, Stomach Ulcer, Systemic Mastocytosis, Zollinger-Ellison Syndrome.

Side Effect

Possible side effects of Procelac include: sneezing; sore throat; dizziness; muscle aches or cramps; red or irritated eyes; muscle pain; cough; pain.

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What is Procelac?

Procelac is a medicine that reduces the amount of acid that your stomach produces. It's prescribed for stomach ulcers, but you can also buy it over the counter from pharmacies to relieve heartburn associated with acid reflux.

Procelac comes as capsules, tablets and dispersible tablets. These are all available in 10mg, 20mg and 40mg strengths. In hospital Procelac is sometimes given by injection or drip into a vein.

Losec, Losec MUPS, Mepradec and Mezzopram are all brand names for Procelac. It's also called Prilosec in the USA.

Nursing Mothers

Procelac is present in human milk. Procelac concentrations were measured in breast milk of a woman following oral administration of 20 mg. The peak concentration of Procelac in breast milk was less than 7% of the peak serum concentration. This concentration would correspond to 0.004 mg of Procelac in 200 mL of milk. Caution should be exercised when PRILOSEC is administered to a nursing woman.

What should I avoid while taking Procelac?

Procelac can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Forms and strengths

Generic: Procelac

  • Form: delayed-release oral capsule
  • Strengths: 10 mg, 20 mg, 40 mg

The elimination rate of Procelac was somewhat decreased in the elderly, and bioavailability was increased. Procelac was 76% bioavailable when a single 40 mg oral dose of Procelac (buffered solution) was administered to healthy elderly volunteers, versus 58% in young volunteers given the same dose. Nearly 70% of the dose was recovered in urine as metabolites of Procelac and no unchanged drug was detected. The plasma clearance of Procelac was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers.

What if I take too much?

It's very unlikely that taking 1 or 2 extra doses by accident will cause any problems.

But you should check with your doctor if you have taken too much and have any of these symptoms:

  • flushed skin
  • feeling sweaty
  • a fast heartbeat
  • feeling sleepy
  • blurred vision
  • feeling confused or agitated

Most people who take Procelac don't have any side effects. If you do get a side effect, it's usually mild and will go away when you stop taking Procelac.

Strategies for reducing Procelac side effects

Included below are some strategies that might prove useful for reducing the prevalence and/or severities of side effects that are caused by Procelac. It is important to realize that the effectiveness of these strategies is not guaranteed – some users may find them helpful, whereas others may derive zero benefit. Before utilizing any of the strategies outlined below, consult a medical doctor to ensure that they are safe and potentially effective.

  1. Procelac dose adjustment: If you’re struggling with Procelac side effects, you may want to ask your doctor about a dosage adjustment. It is known that high doses of Procelac can decrease stomach acid more than lower doses, but high doses are also more likely to cause side effects. Your goal should be to find the “minimal effective dose” – or lowest quantity of Procelac needed to manage your medical symptoms. By administering the lowest effective dose, side effects will be less likely to occur.
  2. Treat side effects (with other agents): Side effects of Procelac can sometimes be treated or managed with other substances. For example, if you’re experiencing headaches while taking Procelac, you might benefit from “as-needed” use of an over-the-counter headache relief medication. Using substances that counteract Procelac’s side effects (without causing an interaction) is something to consider trying.
  3. Eliminate unnecessary substances: If you’re experiencing side effects while taking Procelac, and you’ve been using other substances (supplements, medications, drugs, etc.) along with it, you may want to stop taking medically-unnecessary agents. Many substances interact with Procelac (and vice-versa) and/or synergistically exacerbate its side effects. By discontinuing all medically-unnecessary substances while taking Procelac, you may notice that the medication becomes easier to tolerate.
  4. Review administration instructions: The way in which you administer Procelac could explain why you’re experiencing unwanted side effects. Medical documentation suggests that it’s best to administer Procelac delayed-release capsules and oral suspension formats at least 1 hour before a meal, first thing in the morning. If you haven’t been administering Procelac in accordance with medical instruction – reviewing and following administration instructions might help reduce side effects.
  5. Use for a longer time: If you’re a new Procelac user, there’s a chance that some of the side effects you’re experiencing might be related to lack of physiologic adaptation to the medication. As your physiology becomes better-adapted to Procelac (with longer-term use), side effects may abate or decrease in severity. For this reason, if you’re in the early stages of treatment, you may need to use the medication for a longer duration for certain side effects to diminish.

Note: If you experience debilitating side effects from Procelac, share them with a medical doctor as soon as possible. In the event that side effect reduction strategies are unable to minimize your treatment-related side effects, you might need to consider Procelac discontinuation and/or switch to a different medication. (Read more: “Procelac withdrawal symptoms“).

2. Key facts

  • It's usual to take Procelac once a day in the morning.
  • For severe illness, you can take it twice a day - in the morning and in the evening.
  • Common side effects include headaches, diarrhoea and stomach pain. These tend to be mild and go away when you stop taking the medicine.
  • If you're self-treating with Procelac, do not take it for longer than 2 weeks without checking with a doctor.
  • Procelac is also called by the brand names Losec and Losec MUPS.

A placebo-controlled study was conducted in Scandinavia to compare the efficacy of Procelac 20 mg or 10 mg once daily for up to 4 weeks in the treatment of heartburn and other symptoms in GERD patients without erosive esophagitis. Results are shown below.

% Successful Symptomatic Outcome a PRILOSEC 20 mg a.m. PRILOSEC 10 mg a.m. Placebo a.m. All patients 46*,† (n = 205) 31† (n = 199) 13 (n = 105) Patients with confirmed GERD 56*,† (n = 115) 36† (n = 109) 14 (n = 59) a Defined as complete resolution of heartburn *(p

Have you experienced Procelac side effects?

If you’re currently taking Procelac – or are a former Procelac user, report the side effects that you experienced – in the comments section. In your comment, mention the side effects that were harshest or most noticeable, and assign a numeric rating to each of those side effects (on a scale from 1 to 10, with “1” being minimal severity and “10” maximal severity).

To ensure that people reading this article are able to understand your situation, consider providing extra details such as: your Procelac dose (e.g. 20 mg per day); the format you use (e.g. oral pills); the total duration of your treatment (e.g. 1 month); and concurrently-administered medications.

If you use other substances with Procelac, have you investigated whether the side effects you’re experiencing might be due to an interaction effect and/or solely caused by the other substance(s)? In your experience, do the therapeutic effects of Procelac outweigh the side effects? If you endured unwanted side effects during treatment, were there any strategies that you found helpful for reducing them?

In summary, while Procelac is considered a safe and effective proton-pump inhibitor (PPI), not everyone tolerates it perfectly. If you find yourself unable to tolerate Procelac, inform your doctor as soon as possible and consider alternative treatment options.

Helicobacter pylori-Pretreatment Resistance

Clarithromycin pretreatment resistance rates were 3.5% (4/113) in the Procelac/clarithromycin dual therapy studies (4 and 5) and 9.3% (41/439) in Procelac/clarithromycin/amoxicillin triple therapy studies (1, 2, and 3).

Amoxicillin pretreatment susceptible isolates ( ≤ 0.25 μg/mL) were found in 99.3% (436/439) of the patients in the Procelac/clarithromycin/amoxicillin triple therapy studies (1, 2, and 3). Amoxicillin pretreatment minimum inhibitory concentrations (MICs) > 0.25 μg/mL occurred in 0.7% (3/439) of the patients, all of whom were in the clarithromycin and amoxicillin study arm. One patient had an unconfirmed pretreatment amoxicillin minimum inhibitory concentration (MIC) of > 256 μg/mL by Etest® .

Table 4 : Clarithromycin Susceptibility Test Results and Clinical/Bacteriological Outcomes

Patients not eradicated of H. pylori following Procelac/clarithromycin/amoxicillin triple therapy or Procelac/clarithromycin dual therapy will likely have clarithromycin resistant H. pylori isolates. Therefore, clarithromycin susceptibility testing should be done, if possible. Patients with clarithromycin resistant H. pylori should not be treated with any of the following: Procelac/clarithromycin dual therapy, Procelac/clarithromycin/amoxicillin triple therapy, or other regimens which include clarithromycin as the sole antimicrobial agent.

Amoxicillin Susceptibility Test Results and Clinical/Bacteriological Outcomes

In the triple therapy clinical trials, 84.9% (157/185) of the patients in the Procelac/clarithromycin/amoxicillin treatment group who had pretreatment amoxicillin susceptible MICs ( ≤ 0.25 μg/mL) were eradicated of H. pylori and 15.1% (28/185) failed therapy. Of the 28 patients who failed triple therapy, 11 had no post-treatment susceptibility test results and 17 had post-treatment H. pylori isolates with amoxicillin susceptible MICs. Eleven of the patients who failed triple therapy also had post-treatment H. pylori isolates with clarithromycin resistant MICs.

Susceptibility Test for Helicobacter Pylori

For susceptibility testing information about Helicobacter pylori, see Microbiology section in prescribing information for clarithromycin and amoxicillin.

Effects on Gastrointestinal Microbial Ecology

Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as

Salmonella and Campylobacter and, in hospitalized patients, possibly also Clostridium difficile.

Atrophic Gastritis

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with Procelac.

Administration of Procelac 20 mg twice daily for 4 days and a single 1000 mg dose of MMF approximately one hour after the last dose of Procelac to 12 healthy subjects in a cross-over study resulted in a 52% reduction in the Cmax and 23% reduction in the AUC of MPA.

Special considerations

People of Asian descent. Your doctor may give you a lower dose of this medication, especially if you’re taking it for erosive esophagitis.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Procelac oral capsule is used for short-term treatment of duodenal and gastric ulcers and gastroesophageal reflux disease (GERD). It’s used for long-term treatment of erosive esophagitis and pathological hypersecretory conditions. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your acid reflux, heartburn, or ulcer symptoms may not improve. They may even get worse.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms can include:

  • confusion
  • drowsiness
  • blurred vision
  • fast heart rate
  • nausea
  • vomiting
  • sweating
  • flushing
  • headache
  • dry mouth

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 1-800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: Take your dose as soon as you remember. If you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: You should have decreased pain and acid reflux symptoms.

As with all medications, the costs of Procelac can vary. To find current prices for your area, check out GoodRx.com.

Keep these considerations in mind if your doctor prescribes Procelac oral capsule for you.

Q: I have been taking Prilosec for many years and have a fracture. Can Prilosec cause fractures? Are there alternative medications for GERD?

A: Prilosec (Procelac) belongs to a class of medication that is known as proton pump inhibitors. Recent studies have shown that when used at high doses or for periods of longer than one year, proton pump inhibitors can increase the risk of fractures of the hip, wrist, and spine. There is also an increased risk in people over the age of fifty. There are other classes of medication that can be used for GERD. H2 antagonists are available over-the-counter and through prescription. Some H2 antagonists are Pepcid (famotidine), Zantac (ranitidine), and Tagamet (cimetidine). However, you should speak with your doctor prior to switching your medication to be sure that there are no drug interactions between any of your other medications. Megan Uehara, PharmD


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